title: High risk of complications with a single incision pelvic floor repair kit: results of a retrospective case series.
abstract: OBJECTIVE
  The aim of this study was to retrospectively assess the extent and severity of the post-operative complications associated with the Pinnacle Pelvic Floor Repair Kit.
  
  
  METHODS
  This is a descriptive analysis of 23 consecutive women who had a prolapse repair with either an anterior (n = 19) or posterior (n = 4) Pinnacle kit. The clinical records of all these patients were available for analysis. Pre-operative data and intra-operative complications were noted. All post-operative complications and repeat surgical interventions were recorded. In addition to pelvic floor symptoms, we looked specifically for pelvic pain and mesh contraction, exposure, extrusion or erosion. Complications were classified according to the joint IUGA/ICS system.
  
  
  RESULTS
  Seventy percent (n = 16) of our cohort experienced at least one complication. All, except one, were following an anterior Pinnacle. 10 patients (43 %) had a tender vaginal mesh prominence, including a contraction band anteriorly or at the vaginal apex. Six (26 %) complained of associated buttock, groin or vaginal pain, while the tenderness was only detected during vaginal examination in 4 (16 %) patients. Three (13 %) patients required vaginal mesh excision for severe pain and one required a second procedure. Three patients (13 %) had vaginal mesh exposure and 8 (35 %) developed de novo stress incontinence. Two patients (8 %) developed symptomatic recurrent prolapse, one following mesh excision owing to large mesh exposure. Another patient had an anterior compartment prolapse above and below a tender contracted anterior vaginal mesh.
  
  
  CONCLUSIONS
  The Pinnacle kit was associated with a high incidence of post-operative complications in this small series.
authors.affiliation: Department of Obstetrics and Gynaecology, Groote Schuur Hospital and University of Cape Town, Anzio Road, Cape Town, 7595, South Africa, stjeffery@gmail.com.
authors.forename: Stephen T
authors.initials: ST
authors.lastname: Jeffery
authors.forename: Kendall
authors.initials: K
authors.lastname: Brouard
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D013509:Gynecologic Surgical Procedures / Q000009:adverse effects* / Q000706:statistics & numerical data; D006801:Humans; D008875:Middle Aged; D056887:Pelvic Organ Prolapse / Q000601:surgery*; D011183:Postoperative Complications / Q000453:epidemiology*; D019736:Prostheses and Implants / Q000009:adverse effects*; D012189:Retrospective Studies; D013019:South Africa / Q000453:epidemiology